Real-World Data for Regulatory Decision Making: Challenges and Possible Solutions for Europe

被引：220

作者：

Cave, Alison ^{[1
]}

Kurz, Xavier ^{[1
]}

Arlett, Peter ^{[1
]}

机构：

[1] European Med Agcy, Pharmacovigilance & Epidemiol Dept, Amsterdam, Netherlands

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2019年 / 106卷 / 01期

关键词：

HEALTH;

D O I：

10.1002/cpt.1426

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Real-world data (RWD) offers the possibility to derive novel insights on the use and performance of medicines in everyday clinical use, complementing rather than competing with evidence from randomized control trials. While Europe is rich in healthcare data, its heterogeneous nature brings operational, technical, and methodological challenges. We present a number of potential solutions to address the full spectrum of regulatory use cases and emphasize the importance of early planning of data collection.

引用

页码：36 / 39

页数：4

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